FDA 510(k) clearances — page 248
clearances on record, most recent first.
Clearances — page 248
24,701–24,800 of 175,699- K180610 — Geister retractor for neuro - and spine surgery
- K180802 — Meta P&Bond
- K181104 — Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style
- K181185 — Change Healthcare Enterprise Viewer
- K181295 — Genesys Spine AIS-C Cervical Stand-Alone System
- K181471 — ACCUFUSE Cervical System
- K181502 — Zio AT ECG Monitoring System, ZEUS System
- K181740 — ZELTIQ CoolSculpting System
- K181799 — ResCUBE Ligament Fixation System
- K182054 — Natrelle 133S Tissue Expander
- K182119 — CD HORIZON Spinal System
- K173952 — Universal SmartECG
- K181069 — Disposable Insulin Pen Needle
- K181367 — Tenex Health TX System with the TXP MicroTip
- K181683 — BD MAX CT/GC/TV 20-Day QC Panel
- K181313 — BenQ Diagnostic Ultrasound System
- K181408 — JO Classic Hybrid Personal Lubricant
- K181473 — DENV Detect NS1 ELISA
- K181483 — Tranquil Interbody System
- K181582 — DemeTECH DemeDIOX absorbable surgical suture
- K172830 — Double Medical Femoral Nail System
- K173541 — EPINAUT
- K173673 — AcuSnare Polypectomy Snare
- K173771 — IOLMaster 700
- K173978 — CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module
- K180040 — NC TREK RX Coronary Dilatation Catheter; NC TREK OTW Coronary Dilatation Catheter; TREK RX Coronary Dilatation Catheter; TREK OTW Coronary Dilatation Catheter; MINI TREK RX Coronary Dilatation Catheter; MINI TREK OTW Coronary Dilatation Catheter; MINI TREK II OTW Coronary Dilatation Catheter
- K180179 — Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw
- K180373 — CancelleX Porous Titanium Lumbar Interbody Device
- K181009 — APTUS CMC-I Fusion Plate System
- K181035 — AOS Small Fragment Plating System Lite
- K181060 — Solitaire 2 and Solitaire Platinum Revascularization Device
- K181386 — NuVasive Brigade Lateral System
- K181609 — RadiForce GX560, GX560-AR
- K182057 — EasyMax BT Self-Monitoring Blood Glucose System
- DEN170090 — MATRx plus
- K170050 — Z-CAD smile
- K173657 — Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter
- K173732 — Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit
- K173784 — Smylic Invisible Clear Aligners
- K173890 — GMK Sphere - Kinematic Alignment
- K180173 — Freespira
- K180186 — Stat Profile Prime Plus Analyzer System
- K181333 — ADVIA Centaur Herpes-1 IgG
- K181334 — ADVIA Centaur Herpes-2 IgG
- K181439 — SpyGlass DS and DS II Direct Visualization System
- K181635 — GMK Sphere CR Tibial Inserts
- K181974 — MyoSure XL Tissue Removal Device for Fluent
- K173024 — Non-invasive blood pressure measurement systems
- K180542 — NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe
- K181312 — GrandioSO x-tra
- K181954 — autoLog IQ Autotransfusion System
- K173197 — Reusable NIBP Cuff
- K173658 — Confidence Blood Glucose Monitoring System
- K180698 — PICO 7 Single Use Negative Pressure Wound Therapy System
- K180957 — exGraft, exGraft Carbon ePTFE Vascular Grafts
- K181013 — Fever Scout
- K181379 — H. PYLORI QUIK CHEK
- K181400 — H. PYLORI CHEK
- K181435 — ATEC Cervical Spacer System
- K181791 — SIMPLYSTRONG, SIMPLYEZEE
- K181973 — Medtronic Model 5392 External Pulse Generator (EPG)
- K181982 — MIDAScope and Introducer Kit, and MIDASystem
- K182004 — PENTAX Medical Endoscopic Ultrasound System
- K170824 — BD Vacutainer Eclipse Signal Blood Collection Needle
- K171377 — Young INFINITY Cordless Handpiece System
- K171890 — BEXCORE Breast Biopsy System, Biopsy Needle
- K180850 — re.t.a Reuseable Tampon Applicator
- K181768 — AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
- K181968 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
- DEN170078 — Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System
- K172492 — Optical Topography System ETG-4100
- K173257 — BTI Dental Implant System UnicCa
- K173509 — Biodegradable Nitrile Powder Free Examination Glove (Blue)
- K173516 — NuBorne Infant Warmer
- K173575 — OsteoReady Dental Implant System
- K173608 — Forest Dental Unit
- K173638 — Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus
- K173663 — Electronic Stethoscope DS3011A
- K173761 — Penumbra System Reperfusion Catheter JET 7
- K173773 — MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT
- K173918 — VersaPAP Positive Airway Pressure (PAP) Device
- K180574 — Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor
- K180775 — Watch-PAT300
- K180943 — BioWaveGO
- K180974 — CBit Series Digital Color Doppler Ultrasound System
- K181074 — Simple Science Antimicrobial Facial and Eyelid Cleanser
- K181306 — Actifuse Flow
- K181713 — Ultraxx Nephrostomy Balloon Catheter Set
- K181767 — Cios Select
- K181923 — Quantum Workstation 12.1
- K181940 — GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement
- K181943 — OSCAR (OSCAR Prime, OSCAR Classic)
- K181966 — SmartPerfusion
- K181983 — PreXion 3D Excelsior
- K173454 — Multi-parameter Patient Monitor, models C30
- K180077 — NeuroQ 3.8
- K180522 — IGTFusion
- K180619 — Bongo
- K181020 — Cytosponge Cell Collection Device
- K181206 — GentleCath Glide Intermittent Urinary Catheter
Data sourced from openFDA. This site is unofficial and independent of the FDA.